Trial Outcomes & Findings for Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers (NCT NCT00750282)

Last Updated: 2014-07-24

Results Overview

Part A: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan which was considered a match for specificity. Standard of truth was the onsite clinical diagnosis. Two Beta-Amyloid Plaque Load (BAPL) algorithms for assessing the normality/abnormality of beta-amyloid plaque load in the brain scans were used. Using algorithm A (Majority Read), a brain scan of a subject with a BAPL score of "1" (without beta-amyloid plaque load) or "2" (with minor beta-amyloid plaque load) was considered normal and a BAPL score of "3" (with significant beta-amyloid plaque load) was considered abnormal. Using algorithm B (Average), a brain scan of a subject with a BAPL score of "1" was considered normal and a brain scan with a BAPL score of "2" or "3" was considered abnormal. Algorithm B was used in Part B and in the final

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

422 participants

Primary outcome timeframe

90 - 110 min after investigational medical product (IMP) injection

Results posted on

2014-07-24

Participant Flow

There were two parts in this study, Part A and Part B. Part A was conducted in Australia, Germany, Switzerland and USA. Subjects were recruited from 17 centers. HVs were age matched to subjects with probable Alzheimer's (AD). Part B was conducted in Australia, Germany, Japan, Switzerland, and USA, subjects recruited from 22 centers.

Part A screened 214 subjects; 113 AD and 101 HV. There were 63 screen failures (40 for inclusion criteria, 14 withdrew consent, 9 for other reasons) and one dropout prior to receiving study drug. Part B screened 392 subjects; 204 AD and 188 HV. There were 118 screen failures for similar reasons and 2 dropouts prior to receiving study drug.

Participant milestones

Participant milestones
Measure	Part A Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.	Part A Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Overall Study STARTED	69	82	126	148
Overall Study COMPLETED	69	81	125	147
Overall Study NOT COMPLETED	0	1	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Healthy Volunteers n=69 Participants Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part A Alzheimer Patients n=81 Participants Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Healthy Volunteers n=125 Participants Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Alzheimer Patients n=147 Participants Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Total n=422 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	15 Participants n=4 Participants	78 Participants n=21 Participants
Age, Categorical >=65 years	46 Participants n=5 Participants	62 Participants n=7 Participants	104 Participants n=5 Participants	132 Participants n=4 Participants	344 Participants n=21 Participants
Age, Continuous	68.2 years STANDARD_DEVIATION 6.86 • n=5 Participants	70.7 years STANDARD_DEVIATION 7.82 • n=7 Participants	70.7 years STANDARD_DEVIATION 6.30 • n=5 Participants	73.9 years STANDARD_DEVIATION 7.30 • n=4 Participants	71.4 years STANDARD_DEVIATION 7.36 • n=21 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	36 Participants n=7 Participants	52 Participants n=5 Participants	73 Participants n=4 Participants	200 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	45 Participants n=7 Participants	73 Participants n=5 Participants	74 Participants n=4 Participants	222 Participants n=21 Participants
Region of Enrollment United States	8 participants n=5 Participants	3 participants n=7 Participants	22 participants n=5 Participants	31 participants n=4 Participants	64 participants n=21 Participants
Region of Enrollment Australia	9 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants	5 participants n=4 Participants	31 participants n=21 Participants
Region of Enrollment Germany	49 participants n=5 Participants	71 participants n=7 Participants	63 participants n=5 Participants	72 participants n=4 Participants	255 participants n=21 Participants
Region of Enrollment Switzerland	3 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	11 participants n=4 Participants	15 participants n=21 Participants
Region of Enrollment Japan	0 participants n=5 Participants	0 participants n=7 Participants	29 participants n=5 Participants	28 participants n=4 Participants	57 participants n=21 Participants

PRIMARY outcome

Timeframe: 90 - 110 min after investigational medical product (IMP) injection

Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis.(n=146)

Outcome measures

Outcome measures
Measure	AD (Sensitivity) Group n=78 Participants All evaluated subjects with Alzheimer's disease	HV (Specificity) Group n=68 Participants All evaluated healthy volunteers	AD (Sensitivity) Group (Part B) All evaluated subjects with probable Alzheimer's disease from part B	HV (Specificity) Group (Part B) All evaluated healthy volunteers from Part B	Imaging Window 90-110 Min Part B Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B	Imaging Window 110-130 Min Part B Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth Majority Read Sens/ Spec (BAPL2 = abnormal)	79.49 percentage of subjects Interval 70.47 to 88.51	91.18 percentage of subjects Interval 84.38 to 97.97	—	—	—	—
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth Average Sens / Spec (BAPL2 = normal)	74.79 percentage of subjects Interval 65.69 to 83.88	96.08 percentage of subjects Interval 91.85 to 100.3	—	—	—	—

PRIMARY outcome

Timeframe: 90 - 110 min after IMP injection

Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis

Part B: For the calculation of sensitivity/specificity, a patient with probable AD was expected to have a positive florbetaben PET scan, ie,abnormal scan (BAPL scores "2" or "3") which was considered a match for sensitivity. A HV was expected to have a negative florbetaben PET scan, ie,normal scan (BAPL score "1") which was considered a match for specificity. The clinical diagnosis was established by an independent consensus panel (CP) of experts in dementia. Two independent sets of PET data reads were performed. The first set was performed by a panel of three readers who received live, instructor-led training on the visual assessment procedure. The second set was performed by a panel of five separate readers who were trained on the visual assessment procedure with electronic media.

Outcome measures

Outcome measures
Measure	AD (Sensitivity) Group n=116 Participants All evaluated subjects with Alzheimer's disease	HV (Specificity) Group n=118 Participants All evaluated healthy volunteers	AD (Sensitivity) Group (Part B) All evaluated subjects with probable Alzheimer's disease from part B	HV (Specificity) Group (Part B) All evaluated healthy volunteers from Part B	Imaging Window 90-110 Min Part B Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B	Imaging Window 110-130 Min Part B Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. Sens / Spec (average 3 readers)	67.24 percentage of subjects Interval 58.7 to 75.78	96.61 percentage of subjects Interval 93.34 to 99.88	—	—	—	—
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth. Sens / Spec (additional read, median 5 readers)	78.5 percentage of subjects Interval 71.0 to 85.9	89.2 percentage of subjects Interval 83.6 to 94.7	—	—	—	—

SECONDARY outcome

Timeframe: 45 - 60 min and 110 - 130 min after IMP injection

Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis

PET scans from two additional imaging windows (45-60 min and 110-130 min) were visually assessed

Outcome measures

Outcome measures
Measure	AD (Sensitivity) Group n=78 Participants All evaluated subjects with Alzheimer's disease	HV (Specificity) Group n=68 Participants All evaluated healthy volunteers	AD (Sensitivity) Group (Part B) n=116 Participants All evaluated subjects with probable Alzheimer's disease from part B	HV (Specificity) Group (Part B) n=118 Participants All evaluated healthy volunteers from Part B	Imaging Window 90-110 Min Part B Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B	Imaging Window 110-130 Min Part B Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment Sensitivity & Specificity (45-60 min)	73.93 percentage of subjects Interval 64.88 to 82.98	94.61 percentage of subjects Interval 90.36 to 98.85	71.55 percentage of subjects Interval 63.34 to 79.76	94.07 percentage of subjects Interval 89.81 to 96.55	—	—
Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment Sensitivity & Specificity (110-130 min)	70.56 percentage of subjects Interval 60.98 to 80.15	98.01 percentage of subjects Interval 95.65 to 100.37	73.04 percentage of subjects Interval 64.93 to 81.15	96.58 percentage of subjects Interval 93.29 to 99.87	—	—

SECONDARY outcome

Timeframe: 45-60 min, 90-110 min, 110-130 min

Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis

The agreement between 3 blinded readers concerning the visual assessment of abnormality of the brain scan (based on BAPL score) was measured by the kappa coefficient. Kappa values close to 1.0 indicate a high agreement while values close to 0 indicate random agreement.

Outcome measures

Outcome measures
Measure	AD (Sensitivity) Group n=150 Participants All evaluated subjects with Alzheimer's disease	HV (Specificity) Group n=150 Participants All evaluated healthy volunteers	AD (Sensitivity) Group (Part B) n=150 Participants All evaluated subjects with probable Alzheimer's disease from part B	HV (Specificity) Group (Part B) n=272 Participants All evaluated healthy volunteers from Part B	Imaging Window 90-110 Min Part B n=272 Participants Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B	Imaging Window 110-130 Min Part B n=272 Participants Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)	0.56 Kappa coefficient	0.60 Kappa coefficient	0.67 Kappa coefficient	0.78 Kappa coefficient	0.86 Kappa coefficient	0.86 Kappa coefficient

SECONDARY outcome

Timeframe: 90-110 min post injection

Population: All subjects who had PET imaging data and did not have a major protocol violation were included in the analysis

The Standard Uptake Value Ratios for florbetaben signal in the frontal cortex, lateral temporal cortex, parietal cortex, anterior cingulate, posterior cingulate cortex, occipital cortex, and cerebellum (white matter) were determined as a quantitative measure of tracer uptake. The SUV is defined as the ratio of (1) the tissue radioactivity concentration c (in MBq/kg) at time point t, and (2) the injected activity (in MBq, extrapolated to the same time t) divided by the body weight (in kg). These SUV numbers from regions of interest were then used to derive SUV ratios (SUVR) using the SUV from the cerebellar cortex as reference.)

Outcome measures

Outcome measures
Measure	AD (Sensitivity) Group n=78 Participants All evaluated subjects with Alzheimer's disease	HV (Specificity) Group n=68 Participants All evaluated healthy volunteers	AD (Sensitivity) Group (Part B) n=116 Participants All evaluated subjects with probable Alzheimer's disease from part B	HV (Specificity) Group (Part B) n=118 Participants All evaluated healthy volunteers from Part B	Imaging Window 90-110 Min Part B Kappa coefficient estimate for PET data collected 90-110 min post-injection in Part B	Imaging Window 110-130 Min Part B Kappa coefficient estimate for PET data collected 110-130 min post-injection in Part B.
Standard Uptake Value Ratios for Florbetaben Signal Frontal cortex	1.608 ratio Standard Deviation 0.3207 • Interval 61.47 to 78.18	1.295 ratio Standard Deviation 0.1151 • Interval 86.5 to 96.55	1.646 ratio Standard Deviation 0.2905	1.301 ratio Standard Deviation 0.1961	—	—
Standard Uptake Value Ratios for Florbetaben Signal Lateral temporal cortex	1.571 ratio Standard Deviation 0.2881 • Interval 51.44 to 69.25	1.259 ratio Standard Deviation 0.1058 • Interval 92.13 to 99.4	1.619 ratio Standard Deviation 0.2787	1.292 ratio Standard Deviation 0.1620	—	—
Standard Uptake Value Ratios for Florbetaben Signal Parietal cortex	1.528 ratio Standard Deviation 0.2896 • Interval 65.22 to 81.33	1.234 ratio Standard Deviation 0.1161 • Interval 87.58 to 97.16	1.602 ratio Standard Deviation 0.2705	1.267 ratio Standard Deviation 0.1709	—	—
Standard Uptake Value Ratios for Florbetaben Signal Anterior cingulate	1.723 ratio Standard Deviation 0.3522 • Interval 63.34 to 79.76	1.397 ratio Standard Deviation 0.1425 • Interval 89.81 to 98.33	1.786 ratio Standard Deviation 0.3145	1.434 ratio Standard Deviation 0.2387	—	—
Standard Uptake Value Ratios for Florbetaben Signal Posterior cingulate cortex	1.795 ratio Standard Deviation 0.3149 • Interval 66.85 to 82.72	1.422 ratio Standard Deviation 0.1565 • Interval 90.87 to 98.87	1.852 ratio Standard Deviation 0.3187	1.493 ratio Standard Deviation 0.2351	—	—
Standard Uptake Value Ratios for Florbetaben Signal Occipital cortex	1.495 ratio Standard Deviation 0.2203	1.309 ratio Standard Deviation 0.0864	1.560 ratio Standard Deviation 0.2460	1.341 ratio Standard Deviation 0.1281	—	—
Standard Uptake Value Ratios for Florbetaben Signal Composite SUVR	1.620 ratio Standard Deviation 0.29	1.320 ratio Standard Deviation 0.11	1.678 ratio Standard Deviation 0.2699	1.355 ratio Standard Deviation 0.1784	—	—

Adverse Events

Part A Healthy Volunteers

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part A Alzheimer Patients

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B Healthy Volunteers

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Part B Alzheimer Patients

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A Healthy Volunteers n=69 participants at risk Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part A Alzheimer Patients n=81 participants at risk Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Healthy Volunteers n=125 participants at risk Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Alzheimer Patients n=147 participants at risk Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Nervous system disorders Syncope	1.4% 1/69 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/125 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
Cardiac disorders Arrhythmia	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.2% 1/81 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.80% 1/125 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
General disorders Chest pain	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.2% 1/81 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/125 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell endometrial carcinoma	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.80% 1/125 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.

Other adverse events

Other adverse events
Measure	Part A Healthy Volunteers n=69 participants at risk Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part A Alzheimer Patients n=81 participants at risk Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Healthy Volunteers n=125 participants at risk Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions	Part B Alzheimer Patients n=147 participants at risk Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
General disorders Application site erythema	4.3% 3/69 • Number of events 3 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.2% 1/81 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/125 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
General disorders Injection site erythema	1.4% 1/69 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.80% 1/125 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	4.1% 6/147 • Number of events 6 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
General disorders Injection site haematoma	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.6% 2/125 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	5.4% 8/147 • Number of events 8 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
General disorders Injection site irritation	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	3.2% 4/125 • Number of events 4 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.68% 1/147 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
General disorders Injection site pain	0.00% 0/69 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.6% 2/125 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	2.0% 3/147 • Number of events 3 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
Nervous system disorders Headache	5.8% 4/69 • Number of events 4 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/81 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.6% 2/125 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.4% 2/147 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
Skin and subcutaneous tissue disorders Erythema	2.9% 2/69 • Number of events 2 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.2% 1/81 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/125 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	0.00% 0/147 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.
Vascular disorders Haematoma	1.4% 1/69 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	1.2% 1/81 • Number of events 1 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	5.6% 7/125 • Number of events 8 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.	2.7% 4/147 • Number of events 4 • A maximum of 64 days. Up to 56 days during the screening process and 8 days from baseline to second follow-up visit.

Additional Information

Dr. Juergen Hirschfeld

Piramal Imaging

Phone: 49 30 461 1246 15

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60